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Treatment of Graft Failure After Hematopoietic Stem Cell Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02161783
Recruitment Status : Recruiting
First Posted : June 12, 2014
Last Update Posted : December 14, 2022
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Study Description
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Brief Summary:

This is a guideline for the treatment of graft failure after hematopoietic stem cell transplant (HSCT). This regimen, consisting of cyclophosphamide and fludarabine with low dose total body irradiation (TBI) is designed to promote donor engraftment by day 42 after initial graft failure.

The graft will consist of bone marrow or G-CSF mobilized peripheral blood from a haploidentical related donor. The source of stem cells will be determined by the transplant team based on factors such as patient's age, medical history, donor availability and will be according to the current University of Minnesota Blood and Marrow Transplantation Program selection guidelines.


Condition or disease Intervention/treatment
Primary Graft Failure Secondary Graft Failure Drug: Fludarabine Drug: Cyclophosphamide Radiation: Total Body Irradiation Biological: Hematopoietic stem cell infusion

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment of Graft Failure After Hematopoietic Stem Cell Transplantation
Actual Study Start Date : October 6, 2014
Estimated Primary Completion Date : January 24, 2032
Estimated Study Completion Date : January 30, 2032

Resource links provided by the National Library of Medicine

Drug Information available for: Fludarabine

Groups and Cohorts
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Group/Cohort Intervention/treatment
Treatment
This regimen consists of cyclophosphamide and fludarabine with low dose total body irradiation (TBI), followed by hematopoietic stem cell infusion.
 Drug: Fludarabine
Fludarabine 30 mg/m2 IV over 1 hour given on days -6 through -2 of transplant.
Other Name: Fludara

Drug: Cyclophosphamide
Cyclophosphamide 14.5 mg/kg IV over 1-2 hours given on days -6 and -5 from transplant. And Cyclophosphamide 50 mg/kg IV over 2 hours given on days +3 and +4 from transplant.

Radiation: Total Body Irradiation
TBI 200cGy in a single fraction on day -1 from transplant.
Other Name: TBI

Biological: Hematopoietic stem cell infusion
Hematopoietic stem cell infusion given on day 0.
Other Name: HSCT


Outcome Measures
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Primary Outcome Measures :
  1. Rate of donor engraftment [ Time Frame: day 42 ]
    Rate of sustained donor engraftment at day 42 post this transplant.


Secondary Outcome Measures :
  1. Rate of treatment related mortality [ Time Frame: day 100 ]
    Rate of treatment related mortality (TRM) at day 100

  2. Rate of survival [ Time Frame: Day 100 ]
    Rate of survival by day 100.

  3. Rate of survival [ Time Frame: 1 year ]
    Rate of survival at 1 year

  4. Incidence of acute graft-versus-host disease [ Time Frame: Day 100 ]
    Incidence of acute graft-versus-host disease by day 100

  5. Incidence of chronic graft-versus-host disease [ Time Frame: 1 year ]
    Incidence of chronic graft-versus-host disease at 1 year.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Graft failure for
Criteria

Inclusion Criteria:

  • Patients with primary or secondary graft failure, as defined below, may receive a second transplant:

    • Primary graft failure is defined as not achieving an ANC ≥0.5x10^9/L for three consecutive days by day 35 - 42 following the first transplant.
    • Secondary graft failure is defined as achieving an ANC ≥0.5x10^9/L for three consecutive days by day 35 - 42, but subsequently drops below 0.5x10^9/L without recovery.
    • Loss of chimerism is defined as achieving an ANC ≥0.5x10^9/L for three consecutive, but with less than 10% CD15+ donor cells in the marrow or peripheral blood.

  • Recipients should have acceptable organ function defined as:

    • Renal: creatinine < 2.0 (adults) and creatinine clearance > 30. For creatinine clearance < 70, consultation with a BMT pharmacist is necessary for chemotherapy dose adjustments.
    • Hepatic: bilirubin, AST/ALT, ALP < 10 x upper limit of normal
    • Cardiac: left ventricular ejection fraction > 40%

Exclusion Criteria:

  • Uncontrolled infection at the time of transplant.
  • Patients with Fanconi Anemia or other DNA breakage syndromes.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02161783


Contacts
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Contact: Timothy Krepski 612-273-2800 tkrepsk1@fairview.org

Locations
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United States, Minnesota
University of Minnesota Medical Center, Fairview Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Timothy Krepski    612-273-2800    tkrepsk1@fairview.org   
Principal Investigator: Troy C Lund, MD, PhD         
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
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Principal Investigator: Troy C Lund, MD, PhD University of Minnesota
More Information
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Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT02161783    
Other Study ID Numbers: 2013OC003
MT2013-06C ( Other Identifier: University of Minnesota Blood and Marrow Transplant Program )
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: December 14, 2022
Last Verified: December 2022
Keywords provided by Masonic Cancer Center, University of Minnesota:
Hematopoietic stem cell transplant
Additional relevant MeSH terms:
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Cyclophosphamide
Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
 Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists